Trial Outcomes & Findings for Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures (NCT NCT02477839)
NCT ID: NCT02477839
Last Updated: 2021-07-01
Results Overview
The change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-electroencephalogram (EEG) compared to the End-of-Baseline Period video-EEG. Seizure frequency was analyzed using an analysis of covariance (ANCOVA) with terms for treatment, pooled randomized age stratum, pooled center, and Baseline seizure ADF. Seizure ADF was log transformed using the transformation of ln(X+1), where X is the seizure ADF. Baseline seizure ADF was log transformed. Least squares means were based on log-transformed data of the full ANCOVA model.
COMPLETED
PHASE3
255 participants
End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
2021-07-01
Participant Flow
The study started to enroll patients in June 2015 and concluded in May 2020.
Completed study was defined as participants who had "Completed study participant" selected as status at termination. The total number of participants who completed the study comprises of those who completed the Transition Period and the ones that completed the Taper Period after completing the Maintenance Period. Participant Flow refers to the SS.
Participant milestones
| Measure |
Placebo
Participants received matching placebo syrup.
|
Lacosamide
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
128
|
|
Overall Study
Completed Transition Period
|
124
|
117
|
|
Overall Study
Completed Taper After Maintenance
|
0
|
1
|
|
Overall Study
COMPLETED
|
124
|
118
|
|
Overall Study
NOT COMPLETED
|
3
|
10
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo syrup.
|
Lacosamide
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Participant had PGS during V6
|
0
|
1
|
|
Overall Study
Parents decided to stop medication
|
0
|
1
|
|
Overall Study
Lack of tolerability
|
0
|
1
|
|
Overall Study
Exclusion criterion
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures
Baseline characteristics by cohort
| Measure |
Placebo
n=127 Participants
Participants received matching placebo syrup.
|
Lacosamide
n=128 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day.
|
Total Title
n=255 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
127 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.1 months
STANDARD_DEVIATION 13.4 • n=5 Participants
|
25.2 months
STANDARD_DEVIATION 13.6 • n=7 Participants
|
25.6 months
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
101 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)Population: Full Analysis Set (FAS) included all study participants in the Safety Set (SS). The analysis consisted of all study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
The change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-electroencephalogram (EEG) compared to the End-of-Baseline Period video-EEG. Seizure frequency was analyzed using an analysis of covariance (ANCOVA) with terms for treatment, pooled randomized age stratum, pooled center, and Baseline seizure ADF. Seizure ADF was log transformed using the transformation of ln(X+1), where X is the seizure ADF. Baseline seizure ADF was log transformed. Least squares means were based on log-transformed data of the full ANCOVA model.
Outcome measures
| Measure |
Placebo (FAS)
n=120 Participants
Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
|
Lacosamide (FAS)
n=116 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
|
|---|---|---|
|
Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
|
1.44 percent change
Standard Error 0.06
|
1.40 percent change
Standard Error 0.06
|
PRIMARY outcome
Timeframe: From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days)Population: The Safety Set (SS) included all randomized study participants who took at least 1 dose of study medication.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Outcome measures
| Measure |
Placebo (FAS)
n=127 Participants
Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
|
Lacosamide (FAS)
n=128 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
|
|---|---|---|
|
Participant Withdrawals Due to Adverse Events (AEs) During the Study
|
0 percentage of participants
|
1.6 percentage of participants
|
PRIMARY outcome
Timeframe: From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days)Population: The Safety Set (SS) included all randomized study participants who took at least 1 dose of study medication.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Outcome measures
| Measure |
Placebo (FAS)
n=127 Participants
Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
|
Lacosamide (FAS)
n=128 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
|
|---|---|---|
|
Percentage of Participants With Adverse Events Reported Spontaneously by the Participant's Parent(s) and/or Legal Representative(s)/Caregiver(s) (in Accordance With Local Regulation) or Observed by the Investigator
|
59.1 percentage of participants
|
56.3 percentage of participants
|
SECONDARY outcome
Timeframe: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)Population: Full Analysis Set (FAS) included all study participants in the Safety Set (SS). The analysis consisted of all study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
The absolute change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG.
Outcome measures
| Measure |
Placebo (FAS)
n=123 Participants
Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
|
Lacosamide (FAS)
n=121 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
|
|---|---|---|
|
Absolute Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
|
-4.7650 seizures per day
Standard Deviation 18.0115
|
-2.9427 seizures per day
Standard Deviation 7.4938
|
SECONDARY outcome
Timeframe: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)Population: Full Analysis Set (FAS) included all study participants in the Safety Set (SS). The analysis consisted of all study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
The percent change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG.
Outcome measures
| Measure |
Placebo (FAS)
n=122 Participants
Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
|
Lacosamide (FAS)
n=121 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
|
|---|---|---|
|
Percent Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
|
-26.7927 percent change
Standard Deviation 58.5564
|
-32.3564 percent change
Standard Deviation 65.0255
|
SECONDARY outcome
Timeframe: During the End-of-Maintenance Period (Day 24 to Day 27)Population: Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who completed at least 48 hours of interpretable video-EEG recordings during the EOM Period video-EEG.
A study participant was considered seizure-free from all seizures if the End-of-Maintenance (EOM) Period video-EEG had zero seizures reported from all seizure types (not just partial-onset seizures (POS)).
Outcome measures
| Measure |
Placebo (FAS)
n=120 Participants
Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
|
Lacosamide (FAS)
n=117 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
|
|---|---|---|
|
Percentage of Participants Who Achieved 'Seizure-free' Status From All Seizure Types During the End-of-Maintenance (EOM) Period Video-EEG
|
15.8 percentage of participants
|
17.1 percentage of participants
|
SECONDARY outcome
Timeframe: During the End-of-Maintenance Period (Day 24 to Day 27)Population: Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who completed at least 48 hours of interpretable video-EEG recordings during the EOM Period video-EEG.
A study participant was considered seizure free from partial-onset seizures (POS) if the End-of-Maintenance (EOM) Period video-EEG had zero POS reported.
Outcome measures
| Measure |
Placebo (FAS)
n=120 Participants
Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
|
Lacosamide (FAS)
n=117 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
|
|---|---|---|
|
Percentage of Participants Who Achieved 'Seizure-free' Status From Partial-onset Seizure Types Only During the End-of-Maintenance (EOM) Period Video-EEG
|
16.7 percentage of participants
|
18.8 percentage of participants
|
SECONDARY outcome
Timeframe: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)Population: Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
A ≥25% to \<50% response was defined as ≥25% to \<50% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.
Outcome measures
| Measure |
Placebo (FAS)
n=120 Participants
Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
|
Lacosamide (FAS)
n=116 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
|
|---|---|---|
|
Percentage of Participants Experiencing a >=25% to <50% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
|
18.3 percentage of participants
|
18.1 percentage of participants
|
SECONDARY outcome
Timeframe: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)Population: Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
A ≥50% to ≤75% response was defined as ≥50% to ≤75% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.
Outcome measures
| Measure |
Placebo (FAS)
n=120 Participants
Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
|
Lacosamide (FAS)
n=116 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
|
|---|---|---|
|
Percentage of Participants Experiencing a 50% to 75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
|
17.5 percentage of participants
|
10.3 percentage of participants
|
SECONDARY outcome
Timeframe: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)Population: Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
A \>75% response was defined as \>75% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.
Outcome measures
| Measure |
Placebo (FAS)
n=120 Participants
Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
|
Lacosamide (FAS)
n=116 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
|
|---|---|---|
|
Percentage of Participants Experiencing a >75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
|
20.0 percentage of participants
|
31.0 percentage of participants
|
SECONDARY outcome
Timeframe: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)Population: Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
No change was defined as between \<25% reduction and \<25% increase in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.
Outcome measures
| Measure |
Placebo (FAS)
n=120 Participants
Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
|
Lacosamide (FAS)
n=116 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
|
|---|---|---|
|
Percentage of Participants Experiencing no Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures (Between <25% Reduction and <25% Increase) From EOB Period Video-EEG to EOM Period Video-EEG
|
28.3 percentage of participants
|
27.6 percentage of participants
|
SECONDARY outcome
Timeframe: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)Population: Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
An increase was defined as ≥25% increase in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.
Outcome measures
| Measure |
Placebo (FAS)
n=120 Participants
Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
|
Lacosamide (FAS)
n=116 Participants
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
|
|---|---|---|
|
Percentage of Participants Experiencing an Increase in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures of >=25% From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
|
15.0 percentage of participants
|
12.9 percentage of participants
|
Adverse Events
Placebo (SS)
Lacosamide (SS)
Serious adverse events
| Measure |
Placebo (SS)
n=127 participants at risk
Participants received matching placebo syrup, forming the Safety Set (SS).
|
Lacosamide (SS)
n=128 participants at risk
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the SS.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/127 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
1.6%
2/128 • Number of events 2 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
General disorders
Pyrexia
|
0.79%
1/127 • Number of events 1 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
0.00%
0/128 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
Infections and infestations
Oral herpes
|
0.79%
1/127 • Number of events 1 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
0.00%
0/128 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/127 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
0.78%
1/128 • Number of events 1 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.79%
1/127 • Number of events 1 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
0.00%
0/128 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
Infections and infestations
Urinary tract infection
|
0.79%
1/127 • Number of events 1 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
0.00%
0/128 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
Infections and infestations
Viral infection
|
0.00%
0/127 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
0.78%
1/128 • Number of events 1 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.79%
1/127 • Number of events 1 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
0.00%
0/128 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.79%
1/127 • Number of events 1 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
0.00%
0/128 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/127 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
1.6%
2/128 • Number of events 3 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.79%
1/127 • Number of events 1 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
0.00%
0/128 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.79%
1/127 • Number of events 1 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
0.00%
0/128 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
Other adverse events
| Measure |
Placebo (SS)
n=127 participants at risk
Participants received matching placebo syrup, forming the Safety Set (SS).
|
Lacosamide (SS)
n=128 participants at risk
Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the SS.
|
|---|---|---|
|
General disorders
Pyrexia
|
11.8%
15/127 • Number of events 20 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
5.5%
7/128 • Number of events 9 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
General disorders
Irritability
|
4.7%
6/127 • Number of events 6 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
5.5%
7/128 • Number of events 7 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
13/127 • Number of events 14 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
4.7%
6/128 • Number of events 6 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
|
Nervous system disorders
Somnolence
|
3.9%
5/127 • Number of events 6 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
14.1%
18/128 • Number of events 22 • Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60